MAUDE Adverse Event Report: CARDINAL HEALTH, INC. SALEM SUMP; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8888266197
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported when using the anti-reflux valve with the ng tube, it is breaking when they attempt to remove it from the tube.They have had this happen multiple times now so they are thinking it may be a product issue instead of a user/fluke thing.
Event or Problem Description
The customer reported when using the anti-reflux valve with the ng tube, they are breaking when they attempt to remove them from the tube.They have had this happen multiple times now so they are thinking it may be a product issue instead of a user/fluke thing.Per additional information provided on 23jan2025, they were unable to remove the arv from the tube so they had to remove and re-insert another ng tube.
Additional Manufacturer Narrative
There were no samples returned for investigation, but four photos were received.The photos were reviewed, and the reported condition was observed.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.Based on all available information, no conditions were found during manufacturing that could trigger the observed condition.As such, a definitive root cause could not be determined at this time.A quality alert has been issued to the appropriate manufacturing personnel for awareness.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: SALEM SUMP
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 21105995
• Report Number: 1423537-2025-00020
• Device Sequence Number: 8758498
• Product Code: KNT
• UDI-Device Identifier: 10884521007628
• UDI-Public: (01)10884521007628(10)2128533964
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K851444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8888266197
• Device Catalogue Number: 8888266197
• Device Lot Number: 2128533964
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 01/23/2025; 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown